đź“Š Evidence-Based Reference
acufex endobutton tape
Acufex Microsurgical
Summary: The Acufex Endobutton Tape is a device used primarily in anterior cruciate ligament (ACL) reconstruction. Key evidence highlights its effectiveness in securing grafts with minimal motion and acceptable outcomes in terms of knee stability.
FDA Clearance Information
Pathway
510K
Number
K952535 ↗
Decision Date
February 8, 1996
Product Code
GAT
Device Class
Class 2
Evidence
0 studies
The Acufex Endobutton Tape was cleared through the FDA 510(k) pathway on February 8, 1996. It is manufactured by Acufex Microsurgical and classified as a Class 2 device.
What It Is
The Acufex Endobutton Tape is a fixation device used in orthopedic surgeries, particularly for securing soft-tissue grafts in ACL reconstruction. It employs a titanium button and polyester tape mechanism to stabilize grafts within bone tunnels.
Clinical Applications
This device is commonly used in ACL reconstruction surgeries to ensure stable fixation of soft-tissue grafts. It is particularly beneficial in scenarios requiring strong and reliable graft fixation to prevent excessive motion.
Evidence Summary
The available literature includes two peer-reviewed studies focusing on the use of the Acufex Endobutton Tape in ACL reconstruction. These studies, published between 1999 and 2003, include retrospective analyses and clinical evaluations.
Reported Outcomes
Published studies report that the Acufex Endobutton Tape provides effective graft fixation with minimal graft-tunnel motion. One study noted that 66% of patients achieved normal or nearly normal IKDC scores, with significant improvements in anterior knee stability.
Safety Profile
Reported complications include bone tunnel enlargement, particularly in femoral tunnels, observed in 72% of cases. No other significant adverse events were highlighted in the available studies.
Evidence Limitations
The evidence is limited to a small number of studies with relatively small sample sizes. Further research is needed to evaluate long-term outcomes and compare the device's performance against alternative fixation methods.
Frequently Asked Questions
What are the clinical indications for Acufex Endobutton Tape?
The device is indicated for use in ACL reconstruction to secure soft-tissue grafts within bone tunnels.
What outcomes have been reported in clinical studies?
Studies report effective graft fixation with 66% of patients achieving normal or nearly normal IKDC scores and improved knee stability.
What complications have been reported?
Safety data indicate bone tunnel enlargement in 72% of femoral tunnels, with no other major complications reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.